Evaluating a New Way to Prepare Parents of Hospitalized Children for Discharge and Management of Child at Home

Sponsor
Medical College of Wisconsin (Other)
Overall Status
Completed
CT.gov ID
NCT01565785
Collaborator
Children's Hospital and Health System Foundation, Wisconsin (Other), University of Wisconsin, Milwaukee (Other), Marquette University (Other)
104
1
2
18
5.8

Study Details

Study Description

Brief Summary

The purpose of this study is to pilot test the 'Family Self- Management Discharge Preparation Intervention [FSM-DPI]' that focuses on content and delivery methods to support an effective family transition to home self-management after a child's hospitalization.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: The FSM-DPI.
N/A

Detailed Description

The specific aims of the study are:
  1. To estimate the effect of an intervention designed to improve family self-management after discharge of a hospitalized child on:

  2. Family self-management process (e.g., knowledge, self-regulation, and social facilitation)

  3. Proximal family self-management behavioral outcomes, (e.g., post-discharge parental coping difficulty and family impact), and unplanned use of post-discharge services (calls to family/friends, health care providers, hospital; unscheduled office visits, urgent care/ED visits, readmission).

  4. To describe nurse assessment and patient responses to the FSM-DPI.

  5. To compare nurse satisfaction with discharge teaching process when nurses perform discharge teaching using the FSM-DPI vs. the standard discharge teaching approach.

A novel discharge preparation intervention delivered by nurses to parents of hospitalized children who are being discharged home was developed based on previous research conducted by the investigators. The intervention is grounded in the individual and family self-management Theory. To test the impact of the intervention on discharge preparation process and parent outcomes, the investigators will conduct a pilot trial implementation using trained staff nurses to deliver the intervention. To measure the effects of the intervention a difference- in-differences approach with be used with selection of 200 parents with 50 in each of 4 groups: Baseline control 1 (parents assigned for usual care to study nurses before training on the use of the intervention); Baseline control group 2 ( parent assigned for usual care to other than study nurses); Implementation group ( parents assigned to study nurses who will receive the intervention); Concurrent control group ( parent assigned to other than study nurses). The study will be conducted on two nursing units and half of the sample will be selected from each unit using a random selection procedure.

Data to be collected from all parents (baseline control, implementation, concurrent control) on the day of hospital discharge include: Parent enrollment sheet for collection of parent demographics; Quality of Discharge Teaching Scale, Readiness for Hospital Discharge Scale, Care Transition Measure. In addition the CHW Synergy form will be copied from the child's medical record to provide information on child characteristics of the hospitalization. At 3 weeks post-discharge, parents will be contacted by telephone to obtain outcome data using the Post-Coping Difficulty Scale and the PedsQLâ„¢. Parents will also be asked questions about post-discharge utilization of health services.

Nurses will record process measures related to the delivery of the intervention. In addition the nurse of parents in implementation and control groups will complete assessments of patient readiness for discharge using the Readiness for Hospital Discharge Scale and will rate their experience with the discharge process on a survey developed by the research team.

Analysis will provide information about the utility of the FSM-DPI and preliminary data on which to base revisions and enhancements to the intervention and for development of a larger implementation trial.

Study Design

Study Type:
Interventional
Actual Enrollment :
104 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Self-Management Guided Discharge Teaching for Parents of Hospitalized Children: A Pilot Study
Study Start Date :
Feb 1, 2012
Actual Primary Completion Date :
Aug 1, 2013
Actual Study Completion Date :
Aug 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Discharge Prepartion with The FSM-DPI

25 families on each of 2 units will receive the will receive the Family Self-Management-Discharge Preparation Intervention (FSM-DPI). This scripted theory-based intervention is delivered by the study nurse using a e-mobile device. Eight elements of discharge preparation are addressed, the nurse assesses the family status and documents the additional care provided.

Behavioral: The FSM-DPI.
Nurses will assess key elements of family self-management (home care, child's care, practice, medications, watching child, recovery, development, family adjustment and parental support) and address any deficits to facilitate effective discharge and family management of child at home after hospitalization.
Other Names:
  • Tailored
  • behavioral
  • No Intervention: control group

    25 parents on each unit receiving standard of care in discharge preparation.

    Outcome Measures

    Primary Outcome Measures

    1. Post-Coping Difficulty [3 weeks after discharge]

      The Post-Coping Difficulty Scale is a measure of parent perception of difficulty and ability to manage their child's care at home.

    Secondary Outcome Measures

    1. Pediatric Quality of Life (parent report) [3 weeks after discharge]

      The child quality of life (parent as reporter) is a measure with total score and 4 domain scores, physical, emotional, social and school.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Parents must be at least 18 years of age, speak sufficient English to complete paper or online questionnaires, have a child who has been in the hospital for 2 days and is expected to go home on the data of data collection
    Exclusion Criteria:
    • Parents will be excluded if their child is discharged home to hospice care, or if they were in the hospital less than 2 days, were admitted as a short stay, or remain in the hospital

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Hospital of Wisconsin Milwaukee Wisconsin United States 53201

    Sponsors and Collaborators

    • Medical College of Wisconsin
    • Children's Hospital and Health System Foundation, Wisconsin
    • University of Wisconsin, Milwaukee
    • Marquette University

    Investigators

    • Principal Investigator: Kathleen J Sawin, PhD, Children's Hospital and Health System Foundation, Wisconsin
    • Principal Investigator: Marianne Weiss, DNSc, RN, Marquette University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Medical College of Wisconsin
    ClinicalTrials.gov Identifier:
    NCT01565785
    Other Study ID Numbers:
    • 259192-1
    First Posted:
    Mar 29, 2012
    Last Update Posted:
    Nov 17, 2015
    Last Verified:
    Nov 1, 2015
    Keywords provided by Medical College of Wisconsin

    Study Results

    No Results Posted as of Nov 17, 2015